Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 017955
Company: VALEANT INTL
Company: VALEANT INTL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| RETIN-A | TRETINOIN | 0.01% | GEL;TOPICAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/17/1978 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/01/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/20/2001 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/10/2002 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf | |
| 01/25/1999 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/10/2002 | SUPPL-20 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf | |
| 06/10/2002 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16921s021ltr.pdf | |
| 01/24/1992 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/1990 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/28/1990 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 08/28/1990 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/01/1989 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/11/1985 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/23/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1983 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/29/1981 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/06/1982 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/28/1980 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 11/05/1979 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/03/1979 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/10/2002 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
| 06/10/2002 | SUPPL-20 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf | |
| 06/10/2002 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/16921s21s22s25lbl.pdf |
RETIN-A
GEL;TOPICAL; 0.01%
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| RETIN-A | TRETINOIN | 0.01% | GEL;TOPICAL | Prescription | Yes | AB | 017955 | VALEANT INTL |
| TRETINOIN | TRETINOIN | 0.01% | GEL;TOPICAL | Prescription | No | AB | 075589 | PADAGIS US |